The State Board of Medical Examiners (the Board) proposes to readopt N.J.A.C. 13:35 with amendments. These rules were scheduled to expire on March 17, 2010 pursuant to N.J.S.A. 52:14B-5.1. Pursuant to Executive Order No. 1 (2010), the chapter expiration was extended from March 17, 2010 until completion of the review of the rules by the Red Tape Review Group, and until such time as the extended rules are readopted pursuant to the Administrative Procedure Act, N.J.S.A. 52:14B-1 et seq.

The Board has reviewed the existing rules and has determined that they continue to be reasonable, necessary and effective for the purposes for which they were promulgated. The Board proposes to readopt the rules with amendments as summarized and discussed below.

The existing rules proposed for readoption enable the Board to have in place standards and procedures that serve to maintain principles of conduct and practice in the medical profession. The Board also believes that the proposed amendments further that purpose as the amendments clarify and update the language of the rules. The following summary outlines each subchapter and briefly explains the amendments that are proposed as part of this readoption.

Subchapter 1 contains rules concerning medical training. N.J.A.C. 13:35-1.1 outlines the requirements for externship programs and the limitations imposed on medical students when they serve as observers. The Board proposes to amend this rule to recognize that the Educational Commission for Foreign Medical Graduates publishes a list of foreign medical schools in addition to the World Health Organization directory. N.J.A.C. 13:35-1.2 sets forth a process by which an applicant who does not meet the customary requirements for educational programs may obtain licensure. The Board proposes to amend this rule to recognize that the Educational Commission for Foreign Medical Graduates publishes a list of foreign medical schools in addition to the World Health Organization directory. N.J.A.C. 13:35-1.3 is a reserved section. N.J.A.C. 13:35-1.4 permits the Board to grant a license to an applicant who has not completed the requisite post-graduate training but who furnishes proof that he or she has served in the military service as a physician or surgeon in a medical facility.

N.J.A.C. 13:35-1.5 outlines requirements for graduate medical education programs. The Board proposes to amend this rule to recognize that the Educational Commission for Foreign Medical Graduates publishes a list of foreign medical schools in addition to the World Health Organization directory. The Board also proposes to amend this rule to correct a mistaken citation to the Accreditation Council on Graduate Medicine Education (ACGME), to reflect changes to N.J.S.A. 45:1-22 made by P.L. 2001, c. 307, to recognize that a Director need not report an impaired resident who is known to the Board's Impairment Review Committee through participation in the Alternative Resolution Program and to require that the master list of registration applications include any schools that applicants attended. The rule permits the Board to enter an order to temporarily suspend a resident's authority to engage in the practice of medicine or podiatry. The Board proposes to amend this provision so that, if it determines that a resident's continued practice does not constitute clear and imminent danger but could pose a risk to the public health, safety and welfare, it could order the resident to submit to testing and monitoring, psychological evaluation or an assessment of skills.

Subchapter 1A contains standards for New Jersey clinical training programs sponsored by medical schools, which are not eligible for evaluation or approved by agencies recognized by the Board. P.L. 2003, c. 133 created the Advisory Committee on Alternatively Accredited Medical Schools Clinical Clerkships within the Commission on Higher Education, which was vested with authority over clinical clerkships. As the Board no longer has jurisdiction over the conduct of clinical clerkships, the Board proposes to repeal this subchapter.

Subchapter 2 contains rules providing for limited licenses for podiatry and diagnostic testing centers. N.J.A.C. 13:35-2.1 requires an applicant for a podiatric license to have graduated from an approved college of podiatry. N.J.A.C. 13:35-2.2 requires that an applicant have successfully completed an internship or post-graduate program approved by the American Podiatric Medical Association. N.J.A.C. 13:35-2.3 permits the Board to grant a license to practice podiatry to a person who furnishes proof that he or she has fulfilled all the formal requirements established by the Podiatric Practice Act, N.J.S.A. 45:5-1 et seq., and has served at least two years in active military service. N.J.A.C. 13:35-2.4 and 2.5 are reserved. N.J.A.C. 13:35-2.6 sets forth standards governing screening and diagnostic medical testing offices. The Board proposes an amendment, so that licensees required by the rule to send notification via certified letter may use another method of delivery that indicates proof of delivery. N.J.A.C. 13:35-2.7 through 2.12 are reserved. N.J.A.C. 13:35-2.13 sets forth limitations on practice by graduates of medical schools prior to obtaining a license.

Subchapter 2A contains rules concerning the licensure of midwives. N.J.A.C. 13:35-2A.1 sets forth the purpose and scope of the rules. N.J.A.C. 13:35-2A.2 defines terms used in this subchapter. N.J.A.C. 13:35-2A.3 establishes a Midwifery Liaison Committee to the Board. N.J.A.C. 13:35-2A.4 sets forth the application requirements for licensure. The Board proposes to amend this rule to provide the correct name for the entity that accredits midwifery programs and to recognize accreditation by any entities that succeeded this entity. N.J.A.C. 13:35-2A.5 outlines practice standards. The Board proposes to amend this rule to provide the correct name and date of publication of practice standards for certified nurse midwife and certified midwife practice standards.

Subchapter 2B contains rules for physician assistants. N.J.A.C. 13:35-2B.1 sets forth the scope of the subchapter. N.J.A.C. 13:35-2B.2 contains definitions of terms used in the subchapter. The Board proposes to amend this rule to clarify that a physician may be either a medical doctor (M.D.) or a doctor of osteopathic medicine (D.O.). N.J.A.C. 13:35-2B.3 permits physician assistants to engage in clinical practice. Physician assistants must practice under the direct supervision of physicians, limit their practice to the authorized scope of practice, wear identification tags, comply with recordkeeping requirements and file notices of employment for each place of employment.

[page=1311] N.J.A.C. 13:35-2B.4 permits a physician assistant to perform specific procedures, as long as they are within the training and experience of the supervising physician and the physician assistant and are performed only upon the direction of a supervising physician or pursuant to a written protocol. The Board proposes to amend this rule to specify that physician assistants may now prescribe controlled dangerous substances pursuant to P.L. 2005, c. 48. N.J.A.C. 13:35-2B.5 sets forth the requirements an applicant must meet to be eligible for licensure. N.J.A.C. 13:35-2B.6 provides that the Board may refuse to issue or may suspend or revoke a license for any reason set forth in N.J.S.A. 45:1-21.

N.J.A.C. 13:35-2B.7 requires physician assistants to complete continuing education as a prerequisite for biennial license renewal. N.J.A.C. 13:35-2B.8 sets forth the number of continuing education credit hours physician assistants are required to complete. N.J.A.C. 13:35-2B.9 permits the Board to temporarily waive continuing education requirements on an individual basis for reasons of hardship, such as illness or disability, or other good cause. N.J.A.C. 13:35-2B.10 sets forth the duties and responsibilities of supervising physicians. N.J.A.C. 13:35-2B.11 imposes recordkeeping requirements on physician assistants. N.J.A.C. 13:35-2B.12 sets forth the conditions physician assistants must meet before issuing prescriptions and imposes additional requirements when physician assistants prescribe controlled dangerous substances. The Board proposes to amend this rule to correct a citation.

N.J.A.C. 13:35-2B.13 sets forth eligibility requirements for a temporary license. N.J.A.C. 13:35-2B.14 provides that a temporary license holder may not issue prescriptions but may perform all of the procedures within a physician assistant's scope of practice under the direct supervision of a physician. N.J.A.C. 13:35-2B.15 outlines the conditions that must be met before a temporary license holder can render care to a patient. N.J.A.C. 13:35-2B.16 provides an expiration date for a temporary license. N.J.A.C. 13:35-2B.17 sets forth biennial license renewal requirements, including procedures for reinstating and reactivating suspended and inactive licenses. N.J.A.C. 13:35-2B.18 sets forth the prohibition against sexual misconduct.

Subchapter 3 contains rules concerning licensing examinations, endorsements and exemptions from licensure for graduates of medical schools. N.J.A.C. 13:35-3.1 outlines the licensing examination requirements for physicians. N.J.A.C. 13:35-3.2 provides requirements for the granting of a license by endorsement and N.J.A.C. 13:35-3.3 provides for licensure without examination to practice podiatry in New Jersey . N.J.A.C. 13:35-3.4 and 3.5 are reserved. N.J.A.C. 13:35-3.6 sets forth license requirements to direct and supervise a bioanalytical laboratory and for specialties in specific laboratory procedures. N.J.A.C. 13:35-3.7 provides for a limited exemption from licensure for certain physicians at State or county institutions. N.J.A.C. 13:35-3.8 permits the Executive Director of the Board to admit to the licensing examination candidates who are graduates of professional schools and colleges and who have submitted the required documents for admission. N.J.A.C. 13:35-3.9 permits an applicant to postpone the taking of an examination to the next subsequent examination. As the Board no longer administers its own examination, this rule is no longer relevant and the Board proposes to repeal this section.

N.J.A.C. 13:35-3.10 provides for the security of the licensing examination by discouraging certain conduct in the licensing examination process that subverts or attempts to subvert the examination. N.J.A.C. 13:35-3.11 specifies licensing standards for physicians who graduated from medical schools not subject to accreditation process available to schools in the United States and in Canada . The Board proposes to amend this rule to recognize that the list of foreign medical schools published by the Educational Commission for Foreign Medical Graduates, in addition to the World Health Organization directory, satisfies licensure education requirements. The Board also proposes to amend this rule to use the correct name of the Accreditation Council on Graduate Medical Education. N.J.A.C. 13:35-3.11A requires that applicants who completed their education prior to July 1, 2003 complete one year of post-graduate training. Applicants who completed their education after July 1, 2003 are required to complete two years of post-graduate training and to submit proof that they have entered into a contract for a third year of post-graduate training. The Board proposes to amend this rule to provide the correct name and acronym for the Liaison Committee on Medical Education and the Accreditation Council on Graduate Medical Education. N.J.A.C. 13:35-3.12 requires applicants to complete at least two years at a college or university during which they complete at least 60 credits and pass courses in chemistry, physics and biology. The rule permits the Board to waive this requirement if an applicant is certified by a specialty board, holds a doctorate in a health-related field, holds an M.P.H. degree or has been awarded a National Institute of Health Research Award. The Board proposes to amend this rule to include the acronyms for the national entities in the rule. N.J.A.C. 13:35-3.13 requires a criminal history background check of all applicants for initial licensure. The Board proposes to amend this rule to correct a citation. N.J.A.C. 13:35-3.14 sets forth standards for license issuance and renewal, inactive status and the reinstatement of a suspended or inactive license. N.J.A.C. 13:35-3.15 sets forth standards for post-graduate training in accredited hospitals.

Subchapter 4 contains rules governing the performance of surgery. N.J.A.C. 13:35-4.1 defines what is considered a major surgical procedure and specifies who may perform major surgical procedures and who may assist during a major surgical procedure. N.J.A.C. 13:35-4.2 outlines requirements regarding termination of pregnancies. The rule is proposed for amendment to provide the correct title for the Department of Health and Senior Services and to clarify that the rule does not apply to the provision of a medication to a patient designed to terminate a pregnancy.

Subchapter 4A contains rules for the performance of surgery, special procedures and anesthesia services performed in an office setting. The board notes that it will be addressing these rules in a later rulemaking in order to reconcile Board rules with requirements imposed for anesthesia use in ambulatory care facilities by the Department of Health and Senior Services in N.J.A.C. 8:43A-12. N.J.A.C. 13:35-4A.1 delineates the purpose of the subchapter. N.J.A.C. 13:35-4A.2 specifies the scope of the rules, which include staffing and equipment requirements for practitioners and physicians who perform surgery, perform special procedures and administer anesthesia in an office setting. N.J.A.C. 13:35-4A.3 contains definitions for terms used in the subchapter. The rule is proposed for amendment to correct an acronym (in the definition of "advanced cardiac life support trained"), a citation (in the definition of "privileges") and the name of the Accreditation Council of Graduate Medical Education (in the definition of "anesthesiologist). The definition of "monitoring" is also proposed for amendment to recognize that monitoring may include end-tidal carbon dioxide, specifically when general anesthesia is used. N.J.A.C. 13:35-4A.4 requires practitioners who perform surgery or special procedures in an office, and physicians who administer or supervise the administration or monitoring of anesthesia in an office, to establish written policies and procedures.

N.J.A.C. 13:35-4A.5 imposes a duty to report incidents that occur during surgery, special procedures or the administration of anesthesia in an office. N.J.A.C. 13:35-4A.6 enumerates standards for those practitioners who perform surgery and special procedures in an office setting. This rule currently requires that a history or physical examination be performed on a patient within 14 days preceding surgery. The Board proposes to amend this rule to require that the history or physical examination be performed within 30 days preceding surgery to comport with requirements imposed by the Department of Health and Senior Services on ambulatory care facilities and hospitals pursuant to N.J.A.C. 8:43A-24.14 and 8:43G-32.5. N.J.A.C. 13:35-4A.7 enumerates standards for physicians who administer or supervise the administration of anesthesia services in an office setting. The standards cover the provision of pre-anesthesia counseling and patient monitoring, and the recovery of patients after anesthesia. The rule also contains requirements for maintaining patient records and for the discharge of a patient. This rule refers to an "overstay." The Board proposes to amend this rule to use the correct term, "overnight stay."

N.J.A.C. 13:35-4A.8 specifies how general anesthesia must be administered and monitored in an office setting. N.J.A.C. 13:35-4A.9 sets forth how regional anesthesia may be administered and monitored in an office setting and by whom. N.J.A.C. 13:35-4A.10 specifies how conscious sedation may be administered in an office setting and by whom. N.J.A.C. 13:35-4A.11 enumerates those individuals who are permitted to administer minor conduction blocks in an office setting for surgery or special procedures. N.J.A.C. 13:35-4A.12 establishes the procedure for obtaining privileges to provide or supervise the [page=1312] administration and monitoring of general or regional anesthesia, as well as conscious sedation, in an office when the licensee does not hold such privileges at a licensed hospital. N.J.A.C. 13:35-4A.13 outlines the medical equipment, supplies and pharmacological agents which are required in order to provide anesthetic and recovery services. N.J.A.C. 13:35-4A.14 sets forth safety systems and monitoring devices that must be provided in an office in

which anesthesia services are provided. N.J.A.C. 13:35-4A.15 requires that a recovery area be available in an office in which anesthesia services are provided and specifies the equipment that must be available in the recovery area. N.J.A.C. 13:35-4A.16 provides that the equipment required by the rules are subject to inspection and maintenance. N.J.A.C. 13:35-4A.17 sets out specific dates of compliance for various provisions of the rules. These dates have passed and the Board proposes to amend this rule to delete references to compliance date requirements. N.J.A.C. 13:35-4A.18 provides that any violation of the rules is deemed to be professional misconduct.

Subchapter 5 contains rules concerning eye examinations and eyeglasses. N.J.A.C. 13:35-5.1 specifies the minimum requirements necessary to conduct an eye examination. The rule requires that a physician maintain a complete record of the physical examination of the patient, disclose findings and suggest an appropriate course of action to the patient. The Board proposes to amend this rule to reconcile with Federal Fairness to Contact Lens Consumer Act, which requires prescribers to issue a prescription for contact lenses to a consumer upon the completion of a contact lens fitting. N.J.A.C. 13:35-5.2 specifies the minimum standards and tolerances of optical lenses.

Subchapter 6 contains general rules of practice for Board licensees. N.J.A.C. 13:35-6.1 requires that physicians identify and represent themselves in a manner that clearly indicates their plenary licensure and/or practice specialty. The rule further requires that licensees with limited licenses identify themselves in a manner that indicates their profession. The rule refers to AMA accredited allopathic professional school. The Board proposes to amend this rule to reflect that the Liaison Committee on Medical Education accredits such schools, not the AMA. The rule also refers to AOA accredited schools, the Board proposes to amend this rule to provide the full name of the AOA, the American Osteopathic Association. N.J.A.C. 13:35-6.2 outlines the manner in which a physician may issue a pronouncement of death. In order to capture physician-patient relationships that are not recognized in the existing rule, the Board proposes to amend the definition of "attending physician" to delete the term "ongoing" from "ongoing treatment" and to increase the period of time from the last prescription for a patient from six months to 12 months. The Board also proposes to amend N.J.A.C. 13:35-6.2, so that the definition of "attending physician" uses the correct title for a doctor of osteopathic medicine, to clarify language, to correct citation and grammatical mistakes and to add a requirement that physicians are required to utilize the New Jersey Electronic Death Registration System pursuant to N.J.S.A. 26:8-24.1 and N.J.A.C. 8:2A-3.1.

N.J.A.C. 13:35-6.3 specifies that a licensee may not engage in sexual contact with patients with whom the licensee has a patient/physician relationship. The rule further enumerates what the Board considers sexual misconduct by licensees and provides that any violation of the rule constitutes gross or repeated malpractice or professional misconduct. N.J.A.C. 13:35-6.4 permits physicians, when specific conditions have been met, to delegate to medical assistants the administration of intramuscular or subcutaneous injections. The Board proposes to amend this rule to recognize that the National Healthcare Association accredits post-secondary medical assisting education programs and to permit physicians to direct a medical assistant to administer intradermal injections, in addition to the injections that are already permitted.

N.J.A.C. 13:35-6.5 sets forth standards for preparation of patient records, computerized records and access to and release of information. The rule further enumerates provisions for the confidential maintenance of records and for the transfer and disposal of patient records. Subparagraph (b)3viii sets forth procedures that a physician must follow when updating his or her computer record system to comply with requirements in the rules. Such updating must have been completed by October 19, 1993. The Board proposes to delete this subparagraph and replace it with a requirement that any printouts of non-complying computer system records be maintained as part of a patient's records. The Board also proposes to amend this rule to clarify that records from other physicians or healthcare providers that are part of a patient's record must be provided to a patient if he or she requests a copy of the patient record. N.J.A.C. 13:35-6.5(h) sets forth procedures for the handling of records if a licensee ceases his or her practice. This rule requires that licensees publish a notice in a newspaper that sets forth the procedure for retrieving patient records. The Board proposes to amend this rule to require that such a notice include the location at which records will be permanently maintained and that this notice be submitted to the Board.

N.J.A.C. 13:35-6.6 establishes standards for joint protocols between advanced practice nurses and collaborating physicians. N.J.A.C. 13:35-6.7 imposes requirements on physicians who perform new or novel procedures. N.J.A.C. 13:35-6.8 sets forth standards for prescribing, administering or dispensing laetrile. The Board proposes to amend this rule to use the correct name of the Department of Health and Senior Services. N.J.A.C. 13:35-6.9 requires that physicians who provide diagnostic radiological services to other physicians also provide diagnostic radiological services to chiropractors and podiatrists. N.J.A.C. 13:35-6.10 sets forth specific advertising practices that are prohibited and provides standards for advertising of fees and advertising free or discounted services and for testimonials. The Board proposes to amend this rule to use the correct name of the Department of Health and Senior Services.

N.J.A.C. 13:35-6.11 prohibits excessive fees and lists factors that are taken into consideration when determining whether a fee is excessive. N.J.A.C. 13:35-6.12 is reserved. N.J.A.C. 13:35-6.13 outlines the fees that are charged by the Board. N.J.A.C. 13:35-6.14 sets forth standards for the delegation of specific physical modalities by physicians to licensed health care providers and to unlicensed aides. The Board proposes to amend this rule to permit physicians to delegate physical modalities to licensed occupational therapists. N.J.A.C. 13:35-6.15 requires physicians to complete continuing medical education as a prerequisite of license renewal. The Board proposes to amend this rule, so that, when licensees are required to send a certified letter, they may use another method of delivery that indicates proof of delivery.

N.J.A.C. 13:35-6.16 enumerates the permissible professional business practice structures for licensees. The Board proposes to amend this rule to correct citations to other rules and to use the correct name of the Department of Health and Senior Services. N.J.A.C. 13:35-6.17 prohibits licensees from referring a patient to a health care service in which they, or their immediate family, have a significant beneficial interest. The rule also prohibits licensees from giving or receiving anything of value for a referral to or from another for professional services. The Board proposes to amend this rule to correct citations to national accrediting organizations, the Department of Health and Senior Services and to other rules. Since the promulgation of N.J.A.C. 13:35-6.17, the Board has stayed the operation of subsection (e) in response to opposition from ophthalmologists. This subsection allows a licensee to provide patients medications, medical goods and devices. The subsection caps administrative costs at 10 percent of the cost of the item and requires licensees to provide follow-up when a consumer elects to fill a prescription elsewhere. The Board proposes to amend subsection (e) to delete the imposition of a 10 percent cap on profits. The Board will propose changes to N.J.A.C. 13:35-6.16 and 6.17 at a later date to implement P.L. 2009, c. 24.

N.J.A.C. 13:35-6.18 requires physicians and podiatrists to maintain medical malpractice coverage. N.J.A.C. 13:35-6.19 requires licensees to report any changes in the names and addresses of their practice locations, health care facilities or HMOs where they are affiliated, their medical malpractice insurers, health care service entities in which the licensee has a financial interest or any privileges, disciplinary or criminal action taken against the licensee. This rule refers to public records within the meaning of N.J.S.A. 47:1A-1 et seq., which refers to government records; the Board proposes to amend this rule to correct this reference. The Board also proposes to amend this rule to use the correct name of the Department of Health and Senior Services.

N.J.A.C. 13:35-6.20 permits physicians to delegate specific tasks to radiologic technologists and nuclear medicine technicians. The Board proposes to amend this rule to permit physicians to direct technologists to [page=1313] administer filtered sulfur colloids, Lexiscan and Technetium 99M. N.J.A.C. 13:35-6.21 permits licensees to perform medically recognized hair transplantation techniques and prohibits certain other hair replacement techniques. The Board proposes to amend this rule to correct a citation. N.J.A.C. 13:35-6.22 sets forth the requirements for the termination of the licensee-patient relationship. The Board proposes to amend this rule, so that, when licensees are required to send a certified letter, they may use another method of delivery that indicates proof of delivery.

N.J.A.C. 13:35-6.23 requires physicians in office settings to give patients notice that they have the right to have a chaperone present during a breast and pelvic examination (for a female) and during a genitalia or rectal examination (for either a male or female). N.J.A.C. 13:35-6.24 requires licensees to comply with reporting requirements for communicable diseases established by the State Department of Health and Senior Services rules at N.J.A.C. 8:57-1. N.J.A.C. 13:35-6.25 requires physicians and podiatrists to complete continuing medical education in cultural competency training. N.J.A.C. 13:35-6.26 permits physicians to participate in immunization programs with licensed pharmacists authorized by the Board of Pharmacy, who administer vaccines and related emergency medications.

Subchapter 6A deals with declarations of death upon the basis of neurological criteria. N.J.A.C. 13:35-6A.1 provides that the purpose of the subchapter is to implement the Declaration of Death Act, N.J.S.A. 26:6A-1 et seq. N.J.A.C. 13:35-6A.2 contains definitions for terms used in the subchapter. N.J.A.C. 13:35-6A.3 sets forth the qualifications necessary for physicians to perform a clinical brain death examination. N.J.A.C. 13:35-6A.4 establishes the criteria for determining brain death. N.J.A.C. 13:35-6A.5 prohibits a physician who performs a clinical brain death examination from having any involvement with recovery or transplant of organs from the patient. N.J.A.C. 13:35-6A.6 prohibits a declaration of death based on neurological criteria if such a declaration would violate the patient's religious beliefs. N.J.A.C. 13:35-6A.7 requires a physician who performs a clinical brain death examination to document the results of all tests in the patient's record and permits a physician to authorize the pronouncement of death after he or she has made the determinations required by N.J.A.C. 13:35-6A.5. The Board proposes to amend this rule to correct citations to other rules.

Subchapter 7 contains rules governing the prescription, administration and dispensing of drugs. N.J.A.C. 13:35-7.1 contains definitions of terms used in the subchapter. N.J.A.C. 13:35-7.1A requires a prescribing licensee to conduct an examination of a patient before dispensing or prescribing drugs with the exceptions specified in the rule. N.J.A.C. 13:35-7.2 sets forth standards for issuing written prescriptions for drugs, requires the use of New Jersey Prescription Blanks and details the information that must appear on written prescriptions. N.J.A.C. 13:35-7.3 is reserved. N.J.A.C. 13:35-7.4 and 7.4A impose requirements for transmitting prescriptions either by facsimile machine or electronically. The Board proposes to amend N.J.A.C. 13:35-7.4A to correct citations to other rules and to clarify that N.J.A.C. 13:35-7.1A sets forth standards for examinations.

N.J.A.C. 13:35-7.5 permits prescribing licensees to dispense drugs and imposes storage, recordkeeping and labeling requirements and fee limitations on dispensing of drugs. The Board proposes to amend this rule to include reference to the requirements of subsection (h) in subsection (j). N.J.A.C. 13:35-7.5A sets forth limitations for prescribing, ordering, administering and dispensing of drugs for the treatment of obesity. N.J.A.C. 13:35-7.6 enumerates limitations applicable when a licensee prescribes, administers or dispenses controlled substances. The Board proposes to amend this rule to comply with recent changes in Federal and State (P.L. 2009, c. 165) standards for prescribing multiple prescriptions for Schedule II controlled dangerous substances. These standards allow a practitioner to prescribe multiple prescriptions that can equal up to a 90-day supply of a Schedule II controlled dangerous substance, as long as each prescription is issued for a legitimate medical purpose; the practitioner provides written instructions as to the earliest date on which a pharmacy may fill a prescription; the practitioner determines that multiple prescriptions do not create an undue risk of diversion or abuse; and the practitioner complies with all other State and Federal laws and regulations. N.J.A.C. 13:35-7.7 prohibits licensees from prescribing, and, unless registered to conduct a treatment program, prohibits licensees from administering or dispensing controlled substances for detoxification purposes or maintenance treatments, with limited exceptions. N.J.A.C. 13:35-7.8 prohibits prescribing, ordering, administering or dispensing amphetamines and sympathomimetic amines for purposes of dieting or weight management and sets forth standards for the use of such medications for other purposes. N.J.A.C. 13:35-7.9 limits the prescription, administration or dispensation of anabolic steroids to medically necessary purposes. The rule specifies that body building, muscle enhancement and increased muscular strength are not medically necessary purposes. N.J.A.C. 13:35-7.10 provides that a violation of any of the rules in the subchapter may be deemed to constitute indiscriminate dispensing of controlled dangerous substances, gross or repeated malpractice, negligence, incompetence or professional misconduct. The Board proposes to amend this rule to comport with more newly enacted statutes.

Subchapter 8 regulates hearing aid dispensers. N.J.A.C. 13:35-8.1 sets forth the purpose of the subchapter and N.J.A.C. 13:35-8.2 contains definitions of terms used in the subchapter. N.J.A.C. 13:35-8.3 sets forth the training and experience requirements for licensure as a hearing aid dispenser. The Board proposes to amend this rule to provide correct citations to other rules. N.J.A.C. 13:35-8.4 grants the Hearing Aid Dispensers Examining Committee the authority to issue training permits. N.J.A.C. 13:35-8.5 sets forth standards for issuance of a temporary license. The Board proposes to amend this rule to provide correct citations to other rules. N.J.A.C. 13:35-8.6 sets forth the practice requirements and restrictions for temporary licensees. N.J.A.C. 13:35-8.7 requires that every trainee and temporary licensee be supervised and trained by a sponsor. The rule also establishes the duties and responsibilities of a sponsor.

N.J.A.C. 13:35-8.8 establishes the scope of practice for licensed hearing aid dispensers. The rule also distinguishes hearing aid dispensing from the practice of audiology. N.J.A.C. 13:35-8.9 sets forth the requirements a licensed hearing aid dispenser must follow when fitting and dispensing a deep ear canal hearing aid device to a consumer. N.J.A.C. 13:35-8.10 requires that any business entity filling and dispensing hearing aids designate a licensed hearing aid dispenser as a supervising licensee who is responsible for maintaining records.

N.J.A.C. 13:35-8.11 sets forth biennial renewal requirements for licensure and standards for reinstating and reactivating suspended and inactive licenses. N.J.A.C. 13:35-8.12 requires that all equipment necessary for dispensing hearing aids be available at all practice locations and that electrical equipment used in testing hearing aids be inspected and calibrated to assure accuracy. N.J.A.C. 13:35-8.13 prohibits dispensing a hearing aid to a person who has not first been given a hearing examination unless the dispensing consists solely of an exact make and model replacement or issuing a spare aid. The Board proposes to amend this rule, so that a hearing aid may be sold to a person, as long as a hearing examination has been performed within the previous six months. N.J.A.C. 13:35-8.14 sets forth standards for advertising. N.J.A.C. 13:35-8.15 prohibits a licensed hearing aid dispenser from terminating a professional relationship with a customer unless the dispenser has made arrangements for the continuation of services and/or equipment delivery. The rule also prohibits licensed hearing aid dispensers from charging excessive fees.

N.J.A.C. 13:35-8.16 requires a licensed hearing aid dispenser to provide customers with a written itemization of costs of services and equipment. The rule also requires licensed dispensers to retain a copy of records for seven years following a sale. N.J.A.C. 13:35-8.17 dictates that the licensing examination consists of a written and practical examination, sets forth the content of the examination, standards for passage of the examination and procedures to be followed upon failure of all or a portion of the examination. N.J.A.C. 13:35-8.18 sets forth that any violation of the rules may result in disciplinary action and procedural requirements for such action. N.J.A.C. 13:35-8.19 sets forth the fees charged for services provided by the Board. N.J.A.C. 13:35-8.20 specifies the continuing education that is a prerequisite for biennial license renewal.

Subchapter 9 contains rules concerning the practice of acupuncture. N.J.A.C. 13:35-9.1 outlines the purpose and scope of the subchapter. [page=1314] N.J.A.C. 13:35-9.2 sets out definitions for terms used in the subchapter. N.J.A.C. 13:35-9.3 specifies eligibility requirements for certification and the documents that an applicant for certification must submit to the Board. N.J.A.C. 13:35-9.4 and 9.5 outline educational and certification examination requirements. N.J.A.C. 13:35-9.6 specifies the training required for a dentist or physician who wishes to perform acupuncture without obtaining Board certification. N.J.A.C. 13:35-9.7 sets forth restrictions on the use of certain titles by acupuncturists. N.J.A.C. 13:35-9.8 contains the Board's fee schedule.

N.J.A.C. 13:35-9.9 deals with biennial renewal of certification and the procedures for reinstating and reactivating suspended and inactive certifications. N.J.A.C. 13:35-9.10 requires an acupuncturist to display his or her certificate. N.J.A.C. 13:35-9.11 dictates that an acupuncturist may perform acupuncture only if a patient has been referred by a licensed physician. The rule also requires an acupuncturist to explain acupuncture procedures to a patient, including possible complications, and to obtain written consent from the patient before beginning any treatment. N.J.A.C. 13:35-9.12 sets forth an acupuncturist's scope of practice. The rule details procedures that may only be performed by acupuncturists and those procedures that are within acupuncture scope of practice but are not limited solely to acupuncturists. The rule also sets forth the equipment an acupuncturist may use and those items that an acupuncturist is prohibited from using.

N.J.A.C. 13:35-9.13 deals with guest acupuncturists practicing in New Jersey . N.J.A.C. 13:35-9.14 sets forth what constitutes the uncertified practice of acupuncture. N.J.A.C. 13:35-9.15 outlines requirements for disposing of needles and the procedure for sterilization of equipment and N.J.A.C. 13:35-9.16 sets forth patient record requirements.

N.J.A.C. 13:35-9.17 outlines the process of applying for participation in, and the design and approval of, tutorial programs and the registration of apprentices and supervising acupuncturists. N.J.A.C. 13:35-9.18 sets forth the responsibilities of supervising acupuncturists and N.J.A.C. 13:35-9.19 sets forth the duties of acupuncturist apprentices. N.J.A.C. 13:35-9.20 establishes continuing education requirements for certificate holders applying for biennial certificate renewal. Appendix A is reserved.

Subchapter 10 concerns the registration and regulation of athletic trainers. N.J.A.C. 13:35-10.1 outlines the scope and purpose of Subchapter 10. N.J.A.C. 13:35-10.2 contains definitions of terms used in the subchapter. N.J.A.C. 13:35-10.3 sets forth the documents required to be submitted by an applicant for licensure. N.J.A.C. 13:35-10.4 sets forth biennial license renewal requirements and provides procedures for the reinstatement or reactivation of suspended or inactive licenses. N.J.A.C. 13:35-10.5 specifies the activities that may be performed by an athletic trainer. N.J.A.C. 13:35-10.6 provides that any violation of the subchapter shall be deemed a violation of the Athletic Training Practice Act. N.J.A.C. 13:35-10.7 sets forth the fees that are charged by the Board. N.J.A.C. 13:35-10.8 identifies conduct deemed sexual misconduct and prohibits licensees from engaging in such conduct.

Subchapter 11 establishes the Alternative Resolution Program. N.J.A.C. 13:35-11.1 contains definitions of terms used in the subchapter. N.J.A.C. 13:35-11.2 creates the Impairment Review Committee, which reviews matters concerning practitioners who suffer from chemical dependencies or other impairments. N.J.A.C. 13:35-11.3 sets forth how a professional assistance program is to operate and N.J.A.C. 13:35-11.4 provides the duties of the Committee. The Board proposes to amend this rule to correct citations. N.J.A.C. 13:35-11.5 outlines the process for approval and contents of Board agreements with professional assistance programs. N.J.A.C. 13:35-11.6 authorizes the Committee and the professional assistance programs to accept reports from practitioners regarding their colleagues and provides requirements and procedures for such reporting. The Board proposes to amend this rule to correct citations N.J.A.C. 13:35-11.7 is reserved.

Subchapter 12 concerns the licensing and regulation of electrologists, electrologist instructors and electrologists' offices. N.J.A.C. 13:35-12.1 sets forth the purpose and scope of the subchapter. N.J.A.C. 13:35-12.2 sets forth definitions for terms used in the subchapter. N.J.A.C. 13:35-12.3 provides the addresses of the Electrologist Advisory Committee and N.J.A.C. 13:35-12.4 requires licensees to notify the Committee of address changes and specifies consequences of failure to notify the Board of such changes. N.J.A.C. 13:35-12.5 sets forth requirements for the issuance of an electrologist license without examination. N.J.A.C. 13:35-12.6 and 12.7 establish licensing requirements for electrologists and electrology instructors. N.J.A.C. 13:35-12.8 and 12.9 set forth the documents that electrologist and electrology instructor applicants must submit to the Committee. N.J.A.C. 13:35-12.10 establishes licensing requirements for office premises, including minimum office and equipment requirements.

N.J.A.C. 13:35-12.11 sets forth infection control standards for electrologists. N.J.A.C. 13:35-12.12 requires electrologists to post an office license, electrologist license and a list of services performed at an office premise. N.J.A.C. 13:35-12.13 sets forth the examination requirements for electrologist applicants. N.J.A.C. 13:35-12.14 provides procedures for issuance and biennial renewal of licenses and procedures for reinstatement or reactivation of suspended or inactive licenses. N.J.A.C. 13:35-12.15 prohibits the unlicensed practice of electrology, the maintenance of premises for electrology services without an office license, the improper use of titles by unlicensed personas and the aiding and abetting of unlicensed practice.

Subchapter 13 concerns the licensing and regulation of perfusionists. N.J.A.C. 13:35-13.1 sets forth the purpose and scope of the subchapter. N.J.A.C. 13:35-13.2 sets forth definitions for terms used in the subchapter. N.J.A.C. 13:35-13.3 provides the address of the Perfusionist Advisory Committee and N.J.A.C. 13:35-13.4 requires licensees to notify the Committee of address changes and specifies consequences of failure to notify the Board of such changes. N.J.A.C. 13:35-13.5 establishes licensing requirements for those who were practicing prior to 2000. N.J.A.C. 13:35-13.6 establishes licensing requirements for all other applicants. N.J.A.C. 13:35-13.7 provides a grace period to prohibitions against unlicensed practice for certain applicants while an application to practice is pending. N.J.A.C. 13:35-13.8 establishes requirements for licensure through reciprocity. N.J.A.C. 13:35-13.9 dictates that a person shall not engage in perfusion, or use specific titles, unless he or she is licensed as a perfusionist. N.J.A.C. 13:35-13.10 establishes requirements for a temporary license.

N.J.A.C. 13:35-13.11 sets forth requirements for the biennial renewal of licensure. N.J.A.C. 13:35-13.12 and 13.13 establish procedures for the reactivation or reinstatement of an inactive or suspended license. N.J.A.C. 13:35-13.14 requires licensees to notify the Committee of a change in the status of any facility with which they are affiliated. The rule also requires licensees to notify the Committee if they are subject to an investigation or pending action regarding their professional practice. N.J.A.C. 13:35-13.15 sets forth the standards for the Board to suspend, revoke or refuse to issue a license. N.J.A.C. 13:35-13.16 imposes continuing education as a prerequisite to biennial license renewal and specifies the content of such education. N.J.A.C. 13:35-13.17 establishes the Committee's fee schedule.

The Board has determined that the comment period for this notice of proposal shall be 60 days; therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.

Social Impact

The rules proposed for readoption in N.J.A.C. 13:35 affect a wide range of entities and individuals involved in the medical and other professions. The rules establish standards for medical schools, their internship programs, postgraduate training and clinical training programs. The rules set forth procedures for the issuance of limited licenses for podiatry, certified nurse midwives, physician assistants, hearing aid dispensers, athletic trainers, electrologists and perfusionists and plenary licensure for physicians and surgeons.

The rules also establish requirements for Board licensure, and exemption from licensure, licensing examinations and licensure [page=1315] endorsements. The rules affect all applicants who seek

licensure by the Board and all licensees who are subject to the Board or Committees of the Board. These rules regulate the performance of surgery and the administering of anesthesia in an office setting and the prescribing, administration and dispensing of drugs by licensed practitioners. They also provide a mechanism to rehabilitate licensees who face problems of chemical dependency or other impairments.

Through the various procedures, standards and requirements contained in the rules proposed for readoption, the Board has provided for orderly administration of its operations to ensure that qualified individuals are permitted to enter and remain practicing in the medical and affiliated professions. The existing rules, which the Board proposes to readopt have served to protect the public health, safety and welfare by maintaining a high level of competence and professionalism in medical practice. The readoption of the existing rules will continue to maintain the standards established and provide the public the continued protection and confidence in the medical field, which is afforded by the rules.

The rules proposed for amendment will have an impact on the public as well. Proposed amendments to N.J.A.C. 13:35-6.2 will make it easier to find a physician who can pronounce a death. The amendments will also facilitate the use of the New Jersey Electronic Death Registration System by clarifying that physicians are required to utilize the system. This will facilitate the issuance of death certificates. By requiring that notices of practice cessation include the location where patient records will be permanently stored, and by requiring that this notice be sent to the Board, proposed amendments to N.J.A.C. 13:35-6.5 will help to ensure that patients are able to retrieve records when a physician ceases practice. Proposed amendments to N.J.A.C. 13:35-7.6 that comply with Federal standards regarding multiple prescriptions of Schedule II controlled dangerous substances ensure that such medications are available to patients who need them.

Economic Impact

Some of the rules proposed for readoption or amendment will have an economic impact on applicants for licensure or certification, licensees and certificants.

N.J.A.C. 13:35-2A.7, 2B.17, 3.14, 8.20, 9.9, 10.4, 12.14 and 13.11 have an economic impact in that they set forth the process for the imposition of fees for renewal of licensure or certification, late renewal and reinstatement for physicians, midwives, physician assistants, hearing aid dispensers, acupuncturists, athletic trainers, electrologists and perfusionists.

N.J.A.C. 13:35-6.5 limits the fees that a physician may charge for duplication of a patient's record. The proposed amendments would require that the notices that such licensees publish in local newspapers include the permanent location of patient records and would require physicians to submit this notice to the Board. The cost of providing this additional information in the notice and of submitting the notice to the Board will be borne by licensees.

N.J.A.C. 13:35-6.11 may have economic consequences on licensees as the rule prohibits the charging of excessive fees, which may affect the amount of income derived from the professional practice of licensees.

N.J.A.C. 13:35-6.16 details permissible professional practice structures. The rule may have economic consequences because it requires licensees who have a significant beneficial interest in any of the practice structures listed to terminate their employment or professional affiliation once the licensee becomes aware that the practice structure no longer complies with the provisions of the rule.

N.J.A.C. 13:35-6.17 has an economic impact as it regulates the collection of professional fees and prohibits referring a patient to a health care service in which the practitioner has a significant beneficial interest. The rule also prohibits the giving or receipt of gifts, fees, commissions, rebates, bonuses or other forms of compensation.

N.J.A.C. 13:35-8.19, 9.8, 10.17, 12.22 and 13.17 contain fee schedules for the Hearing Aid Dispensers Examination Committee, the Acupuncture Examining Board, the Athletic Training Advisory Committee, the Electrologists Advisory Committee and the Perfusionist Advisory Committee. The schedules set forth applicable fees that these committees charge licensees and certificants. Although these rules have an economic impact upon licensees and certificants, fees charged pursuant to the fee schedules are necessary to defer the expenses of the Board and the respective Committees to oversee the regulation of licensees and certificants.

Federal Standards Statement

The proposed amendments to N.J.A.C. 13:35-5.1 imposes the same requirements on providing prescriptions to patients upon the completion of a contact lens fitting as those imposed by the Fairness to Contact Lens Consumer Act (15 U.S.C. 7601-7610) and Federal Trade Commission's "Contact Lens Rule," 16 CFR 315. Proposed amendments to N.J.A.C. 13:35-7.6 impose the same requirements as those imposed by 21 CFR 1306.12(b)1. None of the other rules proposed for readoption or the proposed amendments are subject to any Federal standards or requirements.

Jobs Impact

The Board does not expect that the rules proposed for readoption and the proposed amendments will result in the creation or loss of jobs in the State.

Agriculture Industry Impact

The Board believes that the rules proposed for readoption and the proposed amendments will not affect the agriculture industry in the State.

Regulatory Flexibility Analysis

Since practitioners licensed or certified by the Board are individually licensed or certified, under the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., they may be considered "small businesses" for the purposes of the Act.

The costs imposed on small businesses by the rules proposed for readoption with amendments are the same costs that are imposed on all businesses as outlined above in the Economic Impact statement. The Board does not believe that practitioners will need to employ any professional services to comply with the requirements of the rules proposed for readoption with amendments.

The rules that the Board proposes for readoption with amendments and proposed new rules will continue to impose a number of reporting, recordkeeping and compliance requirements upon licensees. Most of the rules contained in N.J.A.C. 13:35 fall within the category of compliance requirements. See the discussion in the Summary above. Subchapter 1 sets forth compliance requirements for externship programs and postgraduate and graduate training. Subchapter 2 contains compliance requirements for podiatrist and the establishment of screening and diagnostic testing offices. Subchapter 2A establishes compliance requirements for midwife practice. Subchapter 2B contains the practice, scope and eligibility requirements for physician assistants. Subchapter 3 establishes examination, endorsement and exemption requirements.

Subchapter 4 contains compliance requirements for qualified first assistants. Subchapter 4A contains compliance requirements for the establishment of offices that perform surgery, anesthesia and special procedures. Subchapter 5 sets forth requirements for conducting eye examinations and standards for optical lenses. Subchapter 6 contains diverse regulations which set forth compliance requirements for the identification of medical practices, the pronouncement of death, the prohibition of sexual misconduct, delegation of injections and physical modalities, advertising and solicitation practices, the establishment of professional business structures and the prohibition of kickbacks and referral fees. Subchapter 6A sets forth compliance requirements for physicians to declare death based on neurological criteria. Subchapter 7 contains compliance requirements for prescribing, administering and dispensing drugs. Subchapters 8, 9 and 10 establish compliance requirements for the practices of hearing aid dispensing, acupuncture and athletic trainers, respectively. Subchapter 11 contains compliance [page=1316] standards for the administration of the Alternative Resolution Program. Subchapters 12 and 13 establish compliance standards for the practice of electrologists and perfusionists.

Several rules in N.J.A.C. 13:35 impose reporting requirements on licensees. N.J.A.C. 13:35-4A.5 imposes a duty to report to the Executive Director of the Board any incident related to surgery, special procedures on the administration of anesthesia within an office which results in a patient's death, transport of the patient to a hospital for observation or treatment for more than 24 hours, or a complication or untoward event. N.J.A.C. 13:35-6.19 requires licensees to report to the Board any changes in names and addresses of practice locations, medical malpractice insurers, health care facility or HMO with which the licensee has an affiliation, changes in practitioners with whom a licensee is associated in practice, and any type of criminal or disciplinary action taken against the licensee. N.J.A.C. 13:35-11.3(a)2 requires that a professional assistance program must report to the Impairment Review Committee any referral which suggests that a licensee has a chemical dependency or other impairment. N.J.A.C. 13:35-13.14 requires perfusionsists to report a change in status to the Perfusionist Advisory Committee.

As the compliance, reporting and recordkeeping requirements contained in the proposed readoption with amendments are necessary to adequately regulate practitioners and protect consumers who use their services, the Board believes that the rules must be uniformly applied to all practitioners and no exemptions are provided based on the size of the business.

Smart Growth Impact

The Board does not believe that the rules proposed for readoption with amendments and repeals will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Housing Affordability Impact

The rules proposed for readoption with amendments will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed rules concern the regulation of licensed or certified physicians, podiatrists, midwives, physician assistants, hearing aid dispensers, acupuncturists, athletic trainers, electrologists and perfusionists.

Smart Growth Development Impact

The rules proposed for readoption with amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2 or within designated centers under the State Development and Redevelopment Plan in New Jersey because the proposed rules concern the regulation of licensed or certified physicians, podiatrists, midwives, physician assistants, hearing aid dispensers, acupuncturists, athletic trainers, electrologists and perfusionists.

Full text of the rules proposed for readoption may be found in the New Jersey Administrative Code at N.J.A.C. 13:35.

Full text of the rules proposed for repeal may be found in the New Jersey Administrative Code at N.J.A.C. 13:35-1A and 3.9.

(a) "Observer" shall mean an undergraduate medical student of an allopathic or osteopathic school accredited either by the Liaison Committee on Medical Education or the American Osteopathic Association or a foreign medical school listed in either the World Health Organization Directory published by the World Health Organization or the International Medical Education Directory (IMED) published by the Educational Commission for Foreign Medical Graduates (ECFMG) and whose graduates are accepted by the New Jersey Board of Medical Examiners as eligible to sit for the licensure examination. Observerships are limited to the student's vacation period in an extra-curricular professional experience as delineated in this section.

(b)-(g) (No change.)

13:35-1.2 Fifth Pathway

(a) The Board shall accept application for licensure from an applicant who does not meet the usual statutory prerequisites for educational background, in the following circumstances to be known as the Fifth Pathway:

1. (No change.)

2. The medical school was approved throughout the applicant's period of education by the government of the country of domicile to confer the degree of Doctor of Medicine and Surgery or its equivalent, and was listed in either the World Health Organization Directory published by the World Health Organization or the International Medical Education Directory (IMED) published by the Educational Commission for Foreign Medical Graduates (ECFMG) ;

1. Has attained the preliminary educational prerequisites for licensure, including:

i. (No change.)

ii. With respect to medical residents, graduation from a medical school which, during each year of attendance, was either accredited by the Liaison Committee on Medical Education (LCME) or the American Osteopathic Association (AOA) or listed in either the World Directory of Medical Schools published by the World Health Organization or the International Medical Education Directory (IMED) published by the Educational Commission for Foreign Medical Graduates (ECFMG), and that the didactic training was completed in the jurisdiction where the school is authorized to confer a medical degree. If the applicant has attended more than one medical school, he or she shall certify that each school attended was accredited or listed in either the World Directory of Medical Schools published by the World Health Organization or the International Medical Education Directory (IMED) published by the Educational Commission for Foreign Medical Graduates (ECFMG) during the same time he or she was matriculated.

iii.-iv. (No change.)

v. With respect to medical students, where clinical clerkships have been completed away from the site of a medical school not approved by the LCME or AOA, satisfactory completion of clinical clerkships of at least four weeks duration each in internal medicine, surgery, obstetrics and gynecology, pediatrics and psychiatry at hospitals [which] that maintained at the time of the clerkship a graduate medical education program in that field accredited by the [LCME] ACGME or the AOA;

2.-5. (No change.)

[page=1317] (d) The Director shall obtain a registration form from each registration applicant and shall retain those forms, which may be subject to review by the Board. The Director shall certify that he or she has personally reviewed the registration form of each registration applicant who has accepted an offer of employment to ascertain that the registration applicant has certified that he or she has attained the prerequisites set forth in (c) above and that the Director is unaware of any information [which] that would contradict any of the representations contained in that registration application form. If the Director shall have reason to question the veracity or reliability of those representations, he or she shall direct the registration applicant to supply the supporting documentation. The Director shall prepare a master list , which contains the names of all registration applicants and the names and addresses of the institutions from which the applicants attended or graduated and shall submit the master list to the Board, along with his or her certification, no later than one month before the registration applicants are to begin participating in the graduate medical education program.

(e)-(j) (No change.)

(k) Upon a duly verified application of the Attorney General, alleging a violation of any act or regulation administered by the Board, which palpably demonstrates that the resident's continued practice would constitute a clear and imminent danger to the public health, safety and welfare, upon notice, the Board may enter an order temporarily suspending the resident's authority to engage in the practice of medicine or podiatry pending a plenary hearing on the charge. If the Board determines that, although continued practice would not constitute clear and imminent danger, the resident's continued practice could pose a risk to the public health, safety and welfare, it may order the resident to submit to medical or diagnostic testing and monitoring or psychological evaluation or an assessment of skills to determine whether the resident can continue to practice with reasonable skill and safety.

(l)-(x) (No change.)

(y) Each hospital offering a program(s) in medicine shall designate one physician who would qualify as a Director to fulfill the responsibilities set forth in this rule. Each hospital offering a podiatry program shall designate one podiatric physician who would qualify as a Director of a podiatry program to fulfill the responsibilities set forth in this rule. The Director may delegate to individual program directors these responsibilities, so long as the Director retains ultimate responsibility for the conduct of the program, except that the Director may not delegate the authority to issue temporary authorizations. In addition to the responsibilities placed upon any Director by this rule, he or she shall:

1.-3. (No change.)

4. Report to the Board if any resident is granted a leave of absence for any reason, relating to a medical or psychiatric illness or to medical competency or conduct, which would represent cause for the withdrawal of the authority to practice, providing an explanation. This duty to report shall not apply if the resident is known to the Board's Impairment Review Committee through participation in the Alternative Resolution Program.

(j) A practitioner designated to be responsible for the management of a screening office not licensed by the Department of Health and Senior Services (DOHSS) shall ensure that reports with respect to screening tests, which yield abnormal results are prepared in writing, include clear direction as to necessary follow-up, and are issued within three business days from the date of receipt of the report by the testing entity.

1.-3. (No change.)

4. In the circumstances set forth in (j)3 above and where immediate clinical follow-up is warranted, efforts shall be made additionally to personally contact the examinee by telephone to confirm that the examinee was made aware of the need to follow up, which efforts shall be documented in the examinee record. When efforts to contact the examinee have been unsuccessful over a period not to exceed 10 days, a letter shall be forwarded to the examinee's address of record by certified mail, return receipt requested, or other proof of delivery, with a copy maintained in the chart, advising of the abnormality and the need for follow-up and referral; and

5. (No change.)

(k)-(s) (No change.)

SUBCHAPTER 2A. LIMITED LICENSES: MIDWIFERY

13:35-2A.4 Application for licensure

(a) An applicant for licensure as a midwife shall submit to the Committee:

1.-2. (No change.)

3. An official transcript from a midwifery program, accredited by the [ACNM] Accreditation Commission for Midwifery Education (ACME), ACC or the Midwifery Education Accreditation Council (MEAC), or their predecessors or successors;

4. A notarized copy of Certification from either ACNM, ACC, NARM[,] or their predecessors or successors;

5.-7. (No change.)

(b) (No change.)

13:35-2A.5 Independent practice

(a) (No change.)

(b) Certified nurse midwives and certified midwives shall conduct their practice pursuant to standards set forth by the ACNM in Standards for the Practice of [Nurse] Midwifery [(1993)] 2003 , as amended and supplemented, available from the American College of Nurse-Midwives, 8403 Colesville Rd., Suite 1550, Silver Spring, MD 20910, which is incorporated herein by reference as part of this rule.

(c)-(d) (No change.)

SUBCHAPTER 2B. LIMITED LICENSES: PHYSICIAN ASSISTANTS

13:35-2B.2 Definitions

The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicated otherwise:

. . .

"Physician" means a person , either an M.D. or D.O., who holds a current, valid license to practice medicine and surgery in this State.

. . .

13:35-2B.4 Scope of practice

(a) (No change.)

(b) A licensee who has complied with the provisions of N.J.A.C. 13:35-2B.3 may perform the following procedures, provided the procedures are within the training and experience of both the supervising physician and the physician assistant, only when the supervising physician directs the licensee to perform the procedures or orders or prescribes the procedures, or the procedures are specified in a written protocol approved by the Board.

13:35-2B.12 Requirements for issuing prescriptions for medications; special requirements for issuance of CDS

(a)-(d) (No change.)

(e) Written prescriptions shall be issued only on New Jersey Prescription Blanks (NJPB), secured from an approved vendor and subject to the required security mandates of the prescription blank program pursuant to N.J.S.A. 45:14-[14] 55 .

13:35-3.11 Standards for licensure of physicians graduated from medical schools not approved by American national accrediting agencies

(a) (No change.)

(b) During the course of the applicant's medical training, and at the time of graduation, the medical school(s) was listed (or notified of eligibility for listing) in either the World Directory of Medical Schools published by the World Health Organization or the International Medical Education Directory (IMED) published by the Educational Commission for Foreign Medical Graduates (ECFMG) , or the medical school(s) was approved and authorized by the country of domicile to confer the degree or certificate evidencing completion of a medical curriculum for the plenary practice of medicine and surgery.

(c)-(d) (No change.)

(e) An applicant who has successfully completed the full basic science studies (or the equivalent of the first two years of an American medical school) in the foreign medical school located in the country of domicile authorized to confer the degree or certificate and has been given academic credit for successful completion of clinical training programs in United States hospitals, with residency programs approved by the [American] Accreditation Council on Graduate Medical Education (ACGME) and the AOA in that field, shall demonstrate that the medical school was approved by the New Jersey State Board of Medical Examiners (Board) to conduct such a program in this State, or that the program was performed in a sister-state and recognized as acceptable by the Board.

(f)-(l) (No change.)

13:35-3.11A Standards for licensure of physicians graduated from medical schools approved by recognized national accrediting agencies

(a) An applicant, who has graduated from a medical school on or after July 1, 1916 and before July 1, 2003 and has received a medical degree from a medical school approved by the Liaison Committee on [Graduate] Medical Education ([LCGME] LCME ) or American Osteopathic Association (AOA) or other recognized national accrediting agency, shall demonstrate to the Board, through submission of documentation, that after receiving a medical degree the applicant has successfully completed at least one year of post-graduate training in a program accredited by the [American] Accreditation Council on Graduate Medical Education (ACGME), the AOA, or any other equivalent group or agency, which the Board, upon review, has determined has comparable standards.

(b) An applicant, who has graduated from a medical school on or after July 1, 2003 and has received a medical degree from a medical school approved by the [LCGME] LCME or AOA or other recognized national accrediting agency, shall demonstrate to the Board, through the submission of documentation, that after receiving a medical degree the applicant has completed and received academic credit for at least two years for post-graduate training in a program accredited by the ACGME, the AOA, or any other equivalent group or agency, which the Board, upon review, has determined has comparable standards, and has a signed contract for a third year of post-graduate training in a program accredited by the ACGME, the AOA, or any other equivalent group or agency, which the Board, upon review, has determined has comparable standards. At least two of the three years of post-graduate training shall be:

1.-2. (No change.)

13:35-3.12 Standards for licensure of physicians with post-secondary educational deficiencies

(a) (No change.)

(b) The Board in its discretion may waive any or all of the pre-medical requirements set forth in (a) above if the credentials presented include proof of the following:

1. Certification by a specialty board approved by the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA) ;

2.-4. (No change.)

(c) The Board in its discretion may waive up to 30 of the required credits and/or all or part of the required subjects if the credentials presented include:

1. Proof of successful completion of the full term of a fellowship program accredited by the Accreditation Council on Graduate Medical Education (ACGME) or the [American Osteopathic Association] AOA acceptable to the Board; or

2. Satisfactory completion of at least three years' clinical training gained through either a residency program or programs that satisfy three years of a nationally prescribed course of training in one discipline pursuant to [Accreditation Council on Graduate Medical Education] ACGME or [American Osteopathic Association] AOA accreditation standards for a particular specialty.

(d) The Board in its discretion may waive any or all of the required subjects if the credentials presented include proof of a score of 80 on each part of the Federation Licensing Examination (FLEX) or the Uniform State Medical Licensing Examination (USMLE) .

(e) (No change.)

13:35-3.13 Criminal history record information

An applicant for initial licensure in the State by the Board shall submit his or her name, address and fingerprints for purposes of a criminal history background check to be conducted by the State of New Jersey pursuant to P.L. 2002, [c.104] c. 104 (N.J.S.A. 45:1-28 et seq.) to determine whether criminal history record information exists [which] that may be considered by the Board in determining whether the applicant shall be licensed in the State. Fees for criminal history record checks shall be paid by applicants for licensure in conformity with P.L. 1994, [c.60] c. 60 (N.J.S.A. 53:1-[7] 20.6 ), P.L. 2002, [c.104] c. 104 (N.J.S.A. 45:1-31) and N.J.A.C. 13:59-1.3 and 1.4. In addition to its use in evaluating an application for initial licensure, the Board may obtain criminal history record information from the Division of State Police for any other purpose authorized by statute or regulation.

SUBCHAPTER 4. SURGERY

13:35-4.2 Termination of pregnancy

(a) This rule is intended to regulate the quality of medical care offered by licensed physicians for the protection of the public, and is not intended to affect rules of the Department of Health and Senior Services establishing institutional requirements. To the extent that rules of the two agencies may overlap, the Medical Board recognizes and relies upon the regulatory procedures of the Department of Health and Senior Services in establishing minimum acceptable standards for non-physician personnel, equipment and resources, the adequacy of the physical plant of the facility in which surgical procedures shall be performed[,] and the facility's interrelationship with an adequate network of health care-related resources, such as ambulance service, etc.

(b) The termination of a pregnancy at any stage of gestation is a procedure, which may be performed only by a physician licensed to practice medicine and surgery in the State of New Jersey . "Procedure" within the meaning of this subsection does not include the issuing of a prescription and/or the dispensing of a pharmaceutical.

(c)-(d) (No change.)

(e) Fifteen weeks through 18 weeks LMP: After 14 weeks LMP and through 18 weeks LMP, a D & E procedure may be performed either in a licensed hospital or in a licensed ambulatory care facility (referred to herein as LACF) authorized to perform surgical procedures by the Department of Health and Senior Services . The physician may perform the procedure in an LACF , which shall have a Medical Director who shall chair a Credentials Committee. The Committee shall grant to operating physicians practice privileges relating to the complexity of the procedure and commensurate with an assessment of the training, experience and skills of each physician for the health, safety and welfare of the public. A list of the privileges of each physician shall contain the effective date of each privilege conferred, shall be reviewed at least biennially[,] and shall be preserved in the files of the LACF.

(f) Nineteen weeks through 20 weeks LMP: A physician planning to perform a D & E procedure after 18 weeks LMP and through 20 weeks LMP in an LACF shall first file with the Board a certification signed by [page=1319] the Medical Director that the physician meets the eligibility standards set forth in (f)1 through 7 below and shall comply with its requirements.

1.-2. (No change.)

3. The procedure shall be done in a location [which] that is designated by the Department of Health and Senior Services as a licensed ambulatory care facility (LACF) authorized to perform surgical procedures as in subsection (e) above. The LACF shall be licensed by the Department of Health and Senior Services as an ambulatory care facility authorized to perform surgical procedures. The facility shall be in current and good standing at all times when surgical procedures are performed there. The LACF shall have a written agreement with an ambulance service assuring immediate transportation of a patient at all times when a patient has been admitted for surgery and until the patient has been discharged from the recovery room.

4.-7. (No change.)

(g) (No change.)

(h) The physician shall make suitable arrangements to insure that all tissues removed shall be properly disposed of by submission to a qualified physician for pathologic analysis or by incineration or by delivery to a person/entity licensed to make biologic and/or tissue disposals in accordance with law, including rules of the Department of Health and Senior Services applicable to an LACF.

SUBCHAPTER 4A. SURGERY, SPECIAL PROCEDURES[,] AND ANESTHESIA SERVICES PERFORMED IN AN OFFICE SETTING

13:35-4A.3 Definitions

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

"Advanced cardiac life support trained" means that a licensee has successfully completed an advanced cardiac life support course offered by a recognized accrediting organization appropriate to the licensee's field of practice. For example, for those licensees treating adult patients, training in advanced cardiac life support (ACLS) is appropriate; for those treating children, training in pediatric advanced life support (PALS) or advanced pediatric life support [( ALPS )] (APLS) is appropriate.

. . .

"Anesthesiologist" means a physician who has successfully completed a residency program in anesthesiology approved by the [American] Accreditation Council of Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA), or who currently is a diplomate of either the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiology, or who was made a Fellow of the American College of Anesthesiology before 1982.

. . .

"Monitoring" means continuous visual observation of a patient and continuous observation of the patient using instruments to measure, display and record the values of certain physiologic variables, such as pulse, oxygen saturation, blood pressure, end-tidal carbon dioxide and respiration.

. . .

"Privileges" means the authorization granted to a practitioner or physician by a hospital licensed in the jurisdiction in which it is located to provide specified services or alternatively by the Board pursuant to N.J.A.C. 13:35-[4.12] 4A.12 , such as surgery or the administration or the supervision of administration of one or more types of anesthetic agents or procedures.

. . .

13:35-4A.6 Standards for performing surgery and special procedures in an office; privileges necessary; pre-procedure counseling; patient records; recovery and discharge

(a)-(b) (No change.)

(c) A practitioner who performs surgery (other than minor surgery) or special procedures in an office shall provide pre-procedure counseling and preparation as follows:

1. (No change.)

2. A history and physical examination shall be performed within the [14] 30 days preceding the proposed surgery either by the practitioner performing the surgery or procedure (as appropriate to that practitioner's scope of practice) or by another physician or physician assistant under the supervision of a physician. Necessary laboratory tests, as guided by the patient's underlying medical condition, shall be conducted within seven days preceding the proposed surgery;

(f) A practitioner who administers or supervises the administration and monitoring of anesthesia services may allow a patient dischargeable to home pursuant to N.J.A.C. 13:35-4A.4(a)9 and 4A.6(d) to remain in the office for a period not to exceed 23 hours in an [overstay] overnight stay area, if the patient may benefit from additional care. The [overstay] overnight stay area shall be staffed by at least one registered professional nurse or physician assistant for each two patients in the [overstay] overnight stay area, the patient's vital signs shall be taken and recorded at least every four hours and a physician shall be able to reach the office within 20 minutes. Appropriate sleeping accommodations, as well as food, shall be provided for the patient.

(g) A practitioner who administers or supervises the administration and monitoring of anesthesia services in an office shall ensure the following prior to discharge:

1.-2. (No change.)

3. That before the patient leaves the office or is transferred to the [overstay] overnight stay area, the physician shall evaluate the patient and shall review and sign the post-anesthesia record; and

4. (No change.)

(h)-(i) (No change.)

13:35-4A.17 Compliance timetables

(a) A practitioner who does not hold privileges at a hospital [and, as of December 16, 2002, was offering and elects to continue offering or chooses to begin offering anesthesia services or surgery or special procedures in the office setting,] shall submit an application to the Board seeking approval pursuant to the alternative privileging process set forth at N.J.A.C. 13:35-4A.12,[no later than December 16, 2003] prior to offering such services . Notwithstanding any other provision in this subchapter, a practitioner who has submitted an application for alternative privileging [pursuant to this subsection] by December 16, 2003 , may continue to offer services for which privileges have been requested until such time as the Board acts upon that application.

(b) A practitioner or physician who offers anesthesia services in an office setting shall purchase and install the equipment and safety systems, as required pursuant to this rule[, no later than December 15, 1998] prior to offering such services . [Alternatively, a practitioner or physician shall have written proof that by October 15, 1998, an order for such equipment has been transmitted to and received by a manufacturer or legitimate vendor of the equipment. Such proof shall include an anticipated date of delivery. All such equipment shall be properly installed in a timely fashion after delivery and shall be used in conformance with this section, no later than December 15, 1998.

(c) All other requirements of this subchapter shall be effective June 15, 1998.]

SUBCHAPTER 5. EYE EXAMINATIONS; EYEGLASSES

13:35-5.1 Minimum eye examination; contact lenses

(a)-(b) (No change.)

(c) An ophthalmologist shall release a copy of a patient's contact lens prescription directly to a patient when a contact lens fitting is completed or at a later time at the patient's request or to a licensed ophthalmologist, a licensed optometrist[,] or a New Jersey licensed ophthalmic dispenser upon either the oral or written request of a patient or a [professional] person acting on a patient's behalf, provided that the prescription is not more than two years old.

[page=1320] SUBCHAPTER 6. GENERAL RULES OF PRACTICE

13:35-6.1 Practice identification

(a) (No change.)

(b) An applicant or current licensee who is a graduate of both [an A.M.A.] a Liaison Committee on Medical Education (LCME)- accredited allopathic professional school and an [A.O.A.] American Osteopathic Association (AOA) -accredited osteopathic professional school may elect to use either M.D. or D.O. as the primary abbreviation following the name and shall notify the Board of such election.

(c)-(f) (No change.)

13:35-6.2 Pronouncement of death

(a) The following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise.

"Attending physician" means any Doctor of Medicine (M.D.) or Doctor of [Osteopathy] Osteopathic Medicine (D.O.) who, prior to the person's death, had attended, supervised or directed [ongoing] medical treatment of the patient as a primary care physician or as a specialist undertaking to treat a significant chronic medical illness, which could lead to death. A physician providing such [ongoing] treatment, who has issued or renewed a prescription issued to the person within the [six] 12 -month period preceding the death, will be deemed to be an attending physician, regardless of whether the physician has personally examined the person within that [six] 12 -month period.

. . .

(b)-(c) (No change.)

(d) Where the apparent death has occurred outside a licensed hospital and the attending or covering physician has been notified but is unable to go to the location to make the determination and pronouncement, said physician may specify another physician or may arrange with a professional nurse (R.N.) or a paramedic in accordance with N.J.A.C. 8:41-[7.5] 3.9 , which requires the relay of findings, including telemetered electrocardiograms, if feasible to attend the presumed decedent and make the determination and pronouncement. In every such instance a written record, which may be contained within a police record, shall be prepared describing the circumstance and identifying the physician and any other person designated as above to perform the death pronouncement responsibility. Such report shall be promptly communicated orally to the attending physician for use in preparation of the death certificate. A copy of the report shall be provided to the physician as soon as practicable.

(e) Where the [probable] apparent death has occurred outside a licensed hospital and the attending or [recovering] covering physician is known but cannot be reached after exercise of reasonable diligence, or no attending physician is known, then any physician, professional nurse or paramedic in accordance with N.J.A.C. 8:41-[7.5] 3.9 may proceed to the scene and make the determination and pronouncement of death. A written record shall be prepared as set forth in (d) above. Following pronouncement of death, the information shall be promptly communicated to the physician for preparation of the death certificate and a copy of the report provided as soon as practicable. If no attending physician is known or if an attending physician is not available to sign in a reasonable period of time, the death shall be immediately reported to the County Medical Examiner .

(f)-(g) (No change.)

(h) Pursuant to N.J.S.A. 26:8-24.1 and N.J.A.C. 8:2A-3.1, an attending or covering physician shall utilize the New Jersey Electronic Death Registration System (NJ-EDRS) to provide the information required by this section.

[(h)] (i) (No change in text.)

13:35-6.4 Delegation of administration of subcutaneous and intramuscular injections to certified medical assistants

(a) The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise:

1. (No change.)

2. "Certified medical assistant" means a graduate of a post-secondary medical assisting education program accredited by the National Healthcare Association (NHA), or its successor, [CAHEA (]The Committee on Allied Health Education and Accreditation of the American Medical Association[)] (CAHEA) , or its successor; [ABHES (]Accrediting Bureau of Health Education Schools[)] (ABHES) , or its successor; or any accrediting agency recognized by the U.S. Department of Education. The educational program shall include, at a minimum, 600 clock hours of instruction and shall encompass training in the administration of intramuscular and subcutaneous injections and instruction and demonstration in: pertinent anatomy and physiology appropriate to injection procedures; choice of equipment; proper technique, including sterile technique; hazards and complications; and emergency procedures. The medical assistant must also maintain current certification from the Certifying Board of the American Association of Medical Assistants (AAMA), the National Center for Competency Testing (NCCT)[,] or registration from the American Medical Technologists (AMT), or any other recognized certifying body approved by the Board.

(b) A physician may direct a certified medical assistant employed in the medical practice in which the physician practices medicine, to administer to the physician's patients an intradermal, intramuscular or subcutaneous injection in the limited circumstances set forth in this section, without being in violation of the pertinent professional practice act implemented by the Board, to the extent such conduct is permissible under any other pertinent law or rule administered by the Board or any other State agency.

(c)-(d) (No change.)

13:35-6.5 Preparation of patient records, computerized records, access to or release of information; confidentiality, transfer or disposal of records

(a) (No change.)

(b) Licensees shall prepare contemporaneous, permanent professional treatment records. Licensees shall also maintain records relating to billings made to patients and third-party carriers for professional services. All treatment records, bills and claim forms shall accurately reflect the treatment or services rendered. Treatment records shall be maintained for a period of seven years from the date of the most recent entry.

1.-2. (No change.)

3. A patient record may be prepared and maintained on a personal or other computer only when it meets the following criteria: